An IRB accustomed to reviewing pharmaceutically-based biomedical protocols might understandably be flummoxed when presented with protocols designed to evaluate botanical medicines. Botanical medicines can differ from pharmaceuticals in important regards: they are complex mixtures of molecules with more than one physiologically active moiety; dose standardization is difficult; and variables such as when a plant is harvested, what part of the plant is used, and how it is processed may affect the medicine’s potency and indications for use. Additionally, and perhaps more concerning for an IRB, is the fact that many botanical medicines currently in use have not gone through preclinical testing and clinical trials to establish biochemical mechanisms, safety, or efficacy; rather, their use is dictated by historical evidence accumulated over decades to millennia.
Instead of being dismayed, IRBs should be thrilled when presented with the opportunity to review a clinical trial of a botanical medicine. Why? For two essential reasons: first, because IRBs are concerned with the health of the human community and their work contributes to the development of new and effective therapies to improve health; and second, because IRBs are concerned with protecting the rights and welfare of the human community and they are eager to remove from the medical armamentarium any therapies that are dangerous or significantly less beneficial than other available therapies.
The aspirational promise of botanical medicine is that therapeutically effective compounds will be identified and validated through carefully designed and conducted trials, and that these compounds may exert therapeutic effects with a lower profile of unwanted side effects, and perhaps at lower cost to patients. Millions of Americans spend billions of dollars in response to the implicit and explicit promises currently extended by the natural products and supplement industry. It behooves IRBs, as necessary actors in the advancement of clinical science, to participate in the substantiation or debunking of these promises.
However, there are ethical issues unique to clinical trials in botanical medicine. How may a biomedical IRB assess the potential benefits and likely harms of a trial for which there is little supporting research literature? How should a consent form be written to convey this dearth of evidence and to neutralize misconceptions based on the often-articulated fallacy of if natural, then safe? Can IRBs have a hand in directing investigators to collect safety data in a systematic way that has not historically been done? How does an IRB know whether an IND is required?
Download the Botanical Medicines in Research whitepaper to see how I address these questions and more.
 Kunle OF, Egharevba HO, Ahmadu PO (2012). Standardization of herbal medicines-A Review. Intl J Biodiversity and Conservation 4(3): 101-112.
 Eisenberg DM, Davis RB, Ettner SL, Appel S, Wilkey S, Van Rompey M and Kessler, RM (1998). Trends in Alternative Medicine Use in the United States, 1990-1997. JAMA 280 (18): 1569-1575